UK-based Plethora Solutions, a developer of products for the treatment of urological disorders, says that its drug candidate PSD597 has achieved symptom improvement in a study examining it as a treatment for interstitial cystitis and painful bladder syndrome.
PSD597 was examined in a Phase II double-blind, placebo-controlled assessment that recruited 102 patients from 22 centers in the USA and Canada. Preliminary analysis of the results indicates that subjects treated with the drug experienced a statistically-significant improvement in disease symptoms including pain, urinary frequency and urgency, measured using the Global Response Assessment scale.
Plethora added that the drug had also achieved secondary endpoints, including symptom and problem indices, and that its therapeutic benefits were maintained for several weeks. The firm also reported that, of those patients who participated in the original program, 86% had elected to take part in an open-label extension study. Full data will be made available later in the year.
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